Newsletter
Published: 20 Dec 2025, 01:41 IST

Novo Nordisk files for CagriSema approval, competing with Eli Lilly’s obesity drug. Merck and Pfizer succeed in bladder cancer study.

• Novo Nordisk files for CagriSema approval in the US.
• Competes with Eli Lilly’s obesity drug orforglipron.
• Merck and Pfizer succeed in bladder cancer study.

Strategic Shift

Novo Nordisk has filed for approval of its obesity drug, CagriSema, in the United States. This move comes as the company seeks to expand its presence in the competitive obesity treatment market. The filing coincides with a similar application by Eli Lilly for its obesity drug, orforglipron. The timing of these filings highlights the intensifying competition between the two pharmaceutical giants. Novo Nordisk’s decision to file for approval now is strategic, aiming to capture a significant share of the growing obesity treatment market.

The obesity epidemic continues to be a major public health concern, affecting millions of individuals worldwide. Novo Nordisk’s CagriSema is designed to address this unmet need by offering a new treatment option for patients struggling with obesity. The company’s application for approval is a critical step in bringing this innovative therapy to market.

Market Context

The global obesity treatment market is projected to reach significant growth in the coming years. According to industry analysts, the market could exceed $15 billion by 2025. This growth is driven by increasing awareness of obesity-related health issues and the demand for effective treatment options. Novo Nordisk’s entry into this market with CagriSema positions the company to capitalize on these trends.

Eli Lilly’s orforglipron, a competing obesity drug, also seeks to gain a foothold in this lucrative market. The simultaneous filings by Novo Nordisk and Eli Lilly underscore the competitive dynamics at play. Both companies are vying for regulatory approval to secure their positions in the obesity treatment landscape.

Pipeline Expansion

Novo Nordisk’s pipeline includes several promising candidates aimed at addressing various metabolic disorders. The company’s focus on innovation and research has led to the development of CagriSema, which combines two active ingredients to enhance weight loss outcomes. Clinical trials have demonstrated positive results, with significant weight reduction observed in patients receiving the treatment.

Meanwhile, Merck & Co. and Pfizer have reported success in a bladder cancer study involving their drug combination of Keytruda and Padcev. The study showed improved outcomes for patients, marking a significant advancement in cancer treatment. This success further solidifies Merck and Pfizer’s positions as leaders in oncology research.

Regulatory Pathway

The regulatory pathway for Novo Nordisk’s CagriSema involves rigorous evaluation by the U.S. Food and Drug Administration (FDA). The agency will assess the drug’s safety and efficacy based on clinical trial data submitted by Novo Nordisk. The outcome of this evaluation will determine whether CagriSema can be marketed in the United States.

Eli Lilly’s orforglipron will undergo a similar regulatory process, with both companies awaiting decisions that could impact their market strategies. The FDA’s review will consider factors such as patient safety, treatment efficacy, and potential side effects.

Competitive Dynamics

The competition between Novo Nordisk and Eli Lilly is emblematic of broader trends in the pharmaceutical industry. Companies are increasingly investing in research and development to bring innovative therapies to market. This competition drives advancements in treatment options and ultimately benefits patients by providing more choices.

In addition to obesity treatments, Novo Nordisk continues to explore opportunities in other therapeutic areas. The company’s commitment to innovation is evident in its robust pipeline and strategic partnerships aimed at expanding its product offerings.

For more updates on Regulatory & Approvals, visit our Regulatory & Approvals section.